Effect of aqueous titanium and diclofenac transdermal patches for pain management in temporomandibular disorders-a randomized clinical trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of pain by VAS scores and during rest and during jaw movements.
研究概览
简要总结
A total of 60 patients will be selected based on the set inclusion and exclusion criteria. A written informed consent will be obtained from each patient before the start of the study. Case history related to TMD will be collected by means of Diagnostic Criteria questionnaire and subsequent clinical examination will be performed. Pain will be assessed by means of visual analog scale. The radiographic examination of the TMJ will be done after the clinical examination to rule out fractures, cysts etc.
Patients will be allocated into 2 groups, Group A[AQUEOUS TITANIUM PATCH 540 ml/l] and Group B[DICLOFENAC PATCH 100 mg] of 30 each by simple random method using a computer generated sequence. Their allocation is concealed by providing them with sequentially numbered opaque envelopes with patient number on outside. The envelope is placed at the custody of the guide and will be opened only during intervention. To eliminate bias, both outcome assessor and patient will be blinded. Code breaking will be performed after statistical analysis. A patch test will be done by the application of test patch on the forearm and observing the skin reaction for 1 hour for detection of allergy. If the patient experiences any signs of allergy, he will be excluded from the study. If no allergic reactions develop the patient will be provided with respective transdermal patches for application onto the painful area for 12 hours a day over 2 weeks duration. No adjuvant therapy is given to the patient during the study period. After 2 weeks the patch application is withdrawn. The patient will be reviewed
and reassessed for outcome measures, pain by visual analog scale during rest and during jaw movements and maximum range of mouth opening, with and without pain periodically on 3rd,7th,15th and 21st days.If patient develops any adverse effects during the study at any point of time, he will be excluded and appropriate therapy will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with temporomandibular disorders presenting with pain based on DC-TMD criteria with Visual analog scale scores of 1-
- •2.Patients who are willing to participate in the study.
排除标准
- •1.Patients who are allergic to titanium, diclofenac and polyurethane materials.
- •2.Patients with history of trauma to temporomandibular and maxillofacial region.
- •3.Patients with previous history of systemic inflammatory conditions of joints like arthritis, gout etc.
- •4.Previously treated patients for temporomandibular disorders.
结局指标
主要结局
Assessment of pain by VAS scores and during rest and during jaw movements.
时间窗: 7th,15th and 21st days
Assessment of maximum range of mouth opening, with and without pain.
时间窗: 7th,15th and 21st days
次要结局
- • Tenderness to palpation of the TMJs (laterally and posteriorly).(7th,15th and 21st days)
研究者
Dr Jeeevitha M
Government Dental College and Research Institute, Bangalore